By Business Wire, March 13, 2013, 07:45:00 AM EDT
ALACHUA, Fla.--(BUSINESS WIRE)--
Biologics Inc. (RTI) (Nasdaq:RTIX), a leading provider of orthopedic
and other biologic implants, is pleased to announce that the company has
received 510(k) clearance from the U.S. Food and Drug Administration
(FDA) for its porcine dermis implant. The implant is intended for use in
soft tissue repair procedures such as hernia repair.
Stored hydrated and ready-to-use, the porcine dermis implant is
comprised of non-crosslinked porcine dermis, designed to act as a
scaffold that allows for neovascularization and reincorporation with the
patient's own tissue. The implants will be made available in various
shapes and sizes.
The implant is sterilized through the Tutoplast® Tissue Sterilization
Process, which is a chemical process to sterilize and preserve tissue
for implantation. Since the first clinical use in 1971, there has been
zero incidence of implant-associated infection from millions of implants
sterilized through the process.
The implants will be processed at RTI's facility in Neunkirchen, Germany
for commercial distribution in the U.S. later this year. The facility
has been validated for processing and has begun production of the
"We are extremely pleased to have received 510(k) clearance in the first
quarter of the year," said Brian K. Hutchison, president and chief
executive officer. "Our newly developed surgical specialties direct
distribution team is eager to add the porcine dermis implant to their
current biologics portfolio, and this clearance supports our schedule
for a full launch later this year."
About RTI Biologics Inc.
RTI Biologics Inc. is a leading provider of sterile biologic implants
for surgeries around the world with a commitment to advancing science,
safety and innovation. RTI prepares human donated tissue and xenograft
tissue for transplantation through extensive testing and screening,
precision shaping and using proprietary, validated processes. These
allograft and xenograft implants are used in orthopedic, dental and
other specialty surgeries.
RTI's innovations continuously raise the bar of science and safety for
biologics - from being the first company to offer precision-tooled bone
implants and assembled technology to maximize each gift of donation, to
inventing validated sterilization processes that include viral
inactivation steps. These processes — BioCleanse®, Tutoplast® and
Cancelle™ SP DBM — have a combined record of more than four million
implants distributed with zero incidence of implant-associated
infection. These processes have been validated by tissue type to
inactivate or remove viruses, bacteria, fungi and spores from the tissue
while maintaining biocompatibility and functionality.
RTI's worldwide corporate headquarters are located in Alachua, Fla.,
with international locations in Germany and France. The company is
accredited by the American Association of Tissue Banks in the United
States and is a member of AdvaMed.
Source: RTI Biologics Inc.